To err is human, to de-risk divine...

We live in an age where we wish to de-risk our investments.  Today, in the highly competitive pharmaceutical sector, if you don't spot the risks before they become a danger to the patient, and a regulator can prove you had the information to mitigate them, you are liable to face one or more of the following: closure of your business unit, a prosecution case that could lead to a jail sentence, and personal responsibility for the serious illness or death of a patient.  So far, so obvious, the need to de-risk.

Never before has it been so important for Clinical Trials teams to be alert for signals that point them in the direction of the possible risks.  Clinical teams should avoid the trap of being locked into rules, regulations, and habits which means they are failing to pay attention to all available evidence about a trial or product which could be highlighting potential risks.  This information comes from all types of sources.  This can include insight that hint of potential problem areas in their product or trial design.  However, because a Clinical Research Organisation (CRO), does not want to provide the sponsor with 'bad' news they may be tempted to ignore or gloss over concerns expressed by patients or doctors because they do not 'fit' protocol or the regulations.  Sponsors need to actively encourage CROs to share all observations and finding.

To read this article in full, please click on the pdf link below:

How to build risk management into Clinical Trials.pdf